NCT04615403

Brief Summary

The study objective is to evaluate the safety of the operative and surgical exchange procedure of Travoprost Intraocular Implant in subjects with open-angle glaucoma or ocular hypertension.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2020

Shorter than P25 for phase_2

Geographic Reach
2 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 4, 2020

Completed
15 days until next milestone

Study Start

First participant enrolled

November 19, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

September 26, 2023

Completed
Last Updated

September 26, 2023

Status Verified

September 1, 2023

Enrollment Period

1.3 years

First QC Date

October 29, 2020

Results QC Date

July 21, 2023

Last Update Submit

September 7, 2023

Conditions

Open Angle Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Ocular Safety

    Number of subjects with Adverse Events including intra-operative and post-operative events (TEAE's) in the study eye

    12 Months

Study Arms (1)

Implantation and Exchange

EXPERIMENTAL

Subjects will undergo implantation and exchange of a Travoprost Intraocular Implant through a small temporal clear corneal incision.

Drug: Travoprost

Interventions

TravoprostDRUG

Implantation and exchange of a Travoprost Intraocular Implant through a clear corneal incision

Implantation and Exchange

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able and willing to attend scheduled follow-up exams for the duration of the study
  • Able and willing to provide written informed consent on the IRB (institutional review board)/IEC (institutional ethics committee)-approved Informed Consent form
  • Best spectacle corrected visual acuity of 20/80 or better in each eye.
  • Previously qualified for GC-009 clinical trial using the Travoprost Intraocular Implant with the travoprost intraocular implant (G2TR) that is present in the study eye.

You may not qualify if:

  • Glaucoma status as follows:
  • Traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders
  • Corneal status as follows:
  • Any active inflammation or edema
  • Any pathology for which, in the investigator's judgement, the following would be either at risk or contraindicated:
  • Implantation of Travoprost Intraocular Implant
  • Compliance to elements of the study protocol (e.g., ophthalmic examinations, follow-up visits)
  • Fellow eye status as follows:
  • Fellow eye actively enrolled in this trial or any other clinical trial
  • Subject status as follows:
  • Pregnant or planning to become pregnant during the course of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Inland Eye Specialists

Hemet, California, 92545, United States

Location

North Bath Eye Associates, Inc.

Petaluma, California, 94954, United States

Location

Eye Center of northern Colorado, PC

Fort Collins, Colorado, 80525, United States

Location

The Eye Associates of Manatee

Manatee, Florida, 34209, United States

Location

Ocala Eye

Ocala, Florida, 34471, United States

Location

Center for Sight

Sarasota, Florida, 34239, United States

Location

Jones Eye Clinic

Sioux City, Iowa, 51104, United States

Location

D'Ambrosio Eye Care

Lancaster, Massachusetts, 01523, United States

Location

Northern New Jersey Eye Institute

South Orange, New Jersey, 07079, United States

Location

Oklahoma Eye Surgeons

Oklahoma City, Oklahoma, 73112, United States

Location

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

Location

Texan Eye

Austin, Texas, 78746, United States

Location

Lehmann Eye Center

Nacogdoches, Texas, 75965, United States

Location

Asian Eye Institute

Makati City, Philippines

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Travoprost

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

CloprostenolProstaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Limitations and Caveats

This was a single arm, open label study in a small number of subjects to assess safety of administration of a second implant and removal of the previous implant.

Results Point of Contact

Title
Study Manager
Organization
Glaukos
ldoan@glaukos.com
949-481-8076

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2020

First Posted

November 4, 2020

Study Start

November 19, 2020

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

September 26, 2023

Results First Posted

September 26, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(13)PH(1)